UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036584
Receipt number R000039947
Scientific Title Development of simulation training programs to improve midwifery practice Skills and its effect
Date of disclosure of the study information 2019/04/24
Last modified on 2019/04/23 20:10:51

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Basic information

Public title

Development of simulation training programs to improve midwifery practice Skills and its effect

Acronym

quasi-experimental study

Scientific Title

Development of simulation training programs to improve midwifery practice Skills and its effect

Scientific Title:Acronym

Development of simulation training programs to improve midwifery practice Skills and its effect

Continuing education program focused on the postpartum period


Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Nursing Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the effect of educational program designed to improve midwifery practice in a period of time immediately after delivery

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Midwifery practice skills to the postpartum bleeding

Key secondary outcomes

Self-efficacy
Self-Directed Learning Readiness (Japanese SDLRS)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Placenta after bleeding for simulation learning

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

The incumbent midwife and not Receive Recognition of Clinical Ladder of Competencies for Midwifery Practice three.

Years of midwive's experience are until ten years from two years

Key exclusion criteria

A midwife receive recognition of Clinical Ladder of Competencies for Midwifery Practice three.

Target sample size

28


Research contact person

Name of lead principal investigator

1st name Mayumi
Middle name
Last name Yamauchi

Organization

Graduate school of nursing Sapporo city university

Division name

doctoral program

Zip code

0600011

Address

Kita11 Nishi13, Chuo-ku, Sapporo 060-0011,JAPAN

TEL

0117262500

Email

1475002@st.scu.ac.jp


Public contact

Name of contact person

1st name Mayumi
Middle name
Last name Yamauchi

Organization

Graduate school of nursing Sapporo city university

Division name

doctoral program

Zip code

0600011

Address

Kita11 Nishi13, Chuo-ku, Sapporo 060-0011,JAPAN

TEL

0117262500

Homepage URL


Email

1475002@st.scu.ac.jp


Sponsor or person

Institute

Graduate school of nursing Sapporo city university

Institute

Department

Personal name



Funding Source

Organization

Graduate school of nursing Sapporo city university

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical Review in Board Graduate school of nursing Sapporo city university

Address

Kita11 Nishi13, Chuo-ku, Sapporo 060-0011,JAPAN

Tel

0117262500

Email

none


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2019 Year 04 Month 24 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2019 Year 04 Month 23 Day

Date of IRB

2019 Year 04 Month 12 Day

Anticipated trial start date

2019 Year 04 Month 23 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 04 Month 23 Day

Last modified on

2019 Year 04 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039947


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name